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Table 5 Study in children: haemagglutinin inhibition (HI) antibodies to A/California/7/2009 (H1N1)v-like strain after vaccination (ATP cohorts for immunogenicity and persistence)

From: Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials

Group

Time

Seroconversion rate

Seroconversion factor

Seroprotection rate

 

point

N

%

(95% CI)

N

Ratio

(95% CI)

N

% ≥1:40

(95% CI)

Q-Pan0.9

Pre

-

-

-

-

-

-

76

36.8

(26.1; 48.7)

Day 21

76

98.7

(92.9; 100)

76

25.7

(20.7; 32.0)

76

98.7

(92.9; 100)

Month 6

73

63.0

(50.9; 74.0)

73

6.6

(5.4; 8.2)

73

75.3

(63.9; 84.7)

D-Pan0.9

Pre

-

-

-

-

-

-

75

32.0

(21.7; 43.8)

Day 21

75

98.7

(92.8; 100)

75

27.1

(22.4; 32.8)

75

98.7

(92.8; 100)

Month 6

74

71.6

(59.9; 81.5)

74

8.0

(6.4; 10.1)

74

85.1

(75.0; 92.3)

Q-Pan1.9

Pre

-

-

-

-

-

-

58

31.0

(19.5; 44.5)

Day 21

58

98.3

(90.8; 100)

58

32.2

(24.7; 42.0)

58

98.3

(90.8; 100)

 

Month 6

58

69.0

(55.5; 80.5)

58

8.9

(6.8; 11.7)

58

79.3

(66.6; 88.8)

  1. N number of subjects with available results (for seroconversion rate and seroconversion factor N - the number of subjects with pre- and post-vaccination results available); % - percentage of subjects; 95% CI - 95% confidence interval. Seroconversion: For initially seronegative subjects (i.e., HI titres <1:10), antibody titre≥ 1:40 after vaccination. For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre. Seroconversion Factor - Geometric Mean Ratio (mean[log10(post-vaccination GMT/pre vaccination GMT]). Pre - prior to vaccination, Day 21 etc- 21 days post vaccination. CBER Criteria were fulfilled if: the lower limit of the 95% CI for SCR was >40%, and the lower limit of the 95% CI for % ≥1:40 was > 70%. CHMP Criteria were fulfilled if: the point estimate for SCR was > 40% and, the post-vaccination point estimate for % ≥1:40 was > 70% and, the point estimate for SCF was >2.5. See Table 1 for details of treatment groups.